FDA 510(k) Application Details - K142132

Device Classification Name	Plasma, Coagulation Control   More FDA Info for this Device
510(K) Number	K142132
Device Name	Plasma, Coagulation Control
Applicant	Diagnostics Stago S.A.S. 125 AVENUE LOUIS ROCHE GENNEVILLIERS 92230 FR Other 510(k) Applications for this Company
Contact	MARIE COMPAGNON-RIOBE Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2014
Decision Date	12/12/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review